Change in dapagliflozin trial eligibility status and prognosis among patients with acute heart failure with preserved ejection fraction

Background: Disease‑modifying therapy for heart failure with preserved ejection fraction (HFpEF) remains limited. The Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction (DELIVER) trial demonstrated the benefits of disease‑modifying therapy and outlined the eligibility criteria for this treatment. The present study investigated how often treatment eligibility changes after hospitalization for acute decompensation and whether eligibility at discharge influences 1‑year outcomes. Methods: This single-center observational cohort study included adults hospitalized for acute HFpEF (left ventricular ejection fraction ≥ 50%) between January 2020 and December 2022. Elevated N‑terminal pro‑B‑type natriuretic peptide and structural heart disease (left atrial enlargement or left ventricular hypertrophy) indicated predischarge DELIVER eligibility. Eligibility was reassessed in event‑free survivors at 1-year follow-up. Primary (all-cause mortality) and secondary (cardiovascular mortality and hospitalization for heart failure [HHF]) outcomes were analyzed over a 1-year period. Kaplan–Meier and Cox analyses with stepwise adjustment were performed. Results: Of 385 patients (mean age: 83.7 ± 13.9 years; men, 53%), 79.2% were DELIVER‑eligible at discharge. Within 1 year, 41.7% of patients who were initially ineligible became eligible, and 85.4% of patients who were eligible remained eligible. The main factor contributing to these changes was progressive left atrial dilatation. Follow-up assessments revealed 35, 20, and 68 HHFs, cardiovascular deaths, and all-cause deaths, respectively. Although eligible patients exhibited high rates of crude 1-year mortality (hazard ratio: 2.43; 95% confidence interval: 1.11–5.30) and cardiovascular mortality and HHFs (hazard ratio: 2.83; 95% confidence interval: 1.13–7.09) than did ineligible patients, no differences in event-free survival rates were observed after adjustment for age, sex, and comorbidities. Conclusion: Although most patients with decompensated HFpEF met the DELIVER criteria, 41.7% of initially ineligible patients became eligible after 1 year. However, no differences were observed in the adjusted 1-year rate of all-cause mortality or cardiovascular mortality and HHFs.